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AVANOS 94839Recalls & reported problems

Avanos Medical, Inc. · MIC-KEY* Gastrostomy Feeding Tube Kit, SECUR-LOK* Extension Sets · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770948393), received between Mar 30, 2020 and Mar 30, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • Foreign Body In Patient1
  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 30, 2020Break; Break

    IT WAS REPORTED THE ENTERAL TUBE SEVERED DURING THE PATIENT'S TRANSFER BETWEEN CHAIRS, AND PART OF TUBE WAS RETAINED INSIDE OF THE PATIENT¿S GASTROINTESTINAL TRACT. THE PATIENT WAS TAKEN TO THE HOSPITAL AND THE MEDICAL TEAM OPTED NOT TO OPERATE AND REMOVE THE SEVERED PIECE. A NEW DEVICE WAS PLACED, PATIENT WENT HOME, PATIENT GOT ILL, AND FOOD SPILLED ONTO THE FLOOR. PATIENT WAS ADMITTED BACK INTO EMERGENCY DEPARTMENT. THE CLINICIANS DECIDED THE SAFEST THING TO DO WAS TO LET THE REMAINING PART OF THE DEVICE PASS THROUGH THE INTESTINAL TRACT.

    Patient problems: Foreign Body In Patient; No Code Available

    MAUDE report 9896808 ↗

Other TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices

All TUBES, GASTROINTESTINAL (AND ACCESSORIES) devices →

Sources and updates

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